Tag Archives: Boehringer Ingelheim

GSK’s Daprodustat Ph3 Data Positive But Not Entirely Clean; BI/Lilly’s Jardiance Demonstrates Consistent Cardio-Renal Benefits in HF; Novo Announces Positive Ph3b STEP 5 Trial Results; CytoDyn Reports Positive Preliminary Data from Ph2 Leronlimab Trial; Roche and Sanofi Mallya Collaboration; Intuity Medical’s Automatic BGM Available in US; Zealand and DEKA Collaboration for Continuous Infusion Pump

A series of cardiometabolic-related news items have been observed from GSK, BI/Lilly, Novo Nordisk, CytoDyn, Roche, Intuity Medical, and Zealand. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

ADA 2021 Key Press Releases (June 28)

On day four of ADA 2021, eight cardiometabolic-related news items were observed from Bigfoot, AZ, Mannkind, Medtronic, Senseonics, BI/Lilly, Sanofi, and REMD Biotherapeutics. Below, FENIX provides context and analysis for the announcements, including thoughts on how the ALT increases observed in REMD’s Ph2 volagidemab trial could spell disaster in Ph3.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

BI and Gubra Partner for Obesity Drug Development; Diabeloop DBLG1 Integrates with Accu-Chek Insight Pump; Tandem Appoints Jordan Pinsker as VP and Medical Director

A series of cardiometabolic-related news items have been observed: Boehringer Ingelheim and Gubra announced a research and licensing agreement for discovering and evaluating targets and innovative peptide compounds for the treatment of obesity; Diabeloop announced the integration of the Accu-Chek Insight insulin pump into the DBLG1 System; Tandem announced Jordan Pinsker from Sansum has been appointed as VP and Medical Director. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

BI Partners With Yale for HF Digital Solutions Trial; New Lilly Lyumjev T1DM TIR Study; Roche Q3 ’20 Earnings Update

A series of diabetes-related news items have been observed: Boehringer Ingelheim and Yale announced a collaboration to evaluate heart failure digital technologies (press release); Lilly initiated new Lyumjev (ultra rapid-acting lispro) + degludec U100 T1DM MDI TIR study; and Roche hosted its Q3 ’20 earnings call (press release; slides). Below, FENIX provides highlights and insights for the respective news items, including thoughts on how the new Lilly Lyumjev trial likely relates to the recent educational partnership between Lilly and Dexcom (previous FENIX insight).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Trijardy XR (empa/lina/met XR FDC) Approved; Trijardy Label and Market Analysis

Late yesterday, Boehringer Ingelheim and Lilly announced FDA approval for their empagliflozin+linagliptin+metformin XR triple FDC, branded as “Trijardy XR.” Below, FENIX has conducted a Trijardy XR label analysis which includes a comparison to AstraZeneca’s Qternmet XR (dapa+saxa+met XR) as well as thoughts on the potential impact of the triple FDCs on the OAD market segment.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Jardiance EMPERIAL Studies Fail to Show HF Symptom Improvement

Boehringer Ingelheim and Lilly announced that the Jardiance EMPERIAL-Preserved and EMPERIAL-Reduced trials failed to meet the respective primary endpoints. Recall, these trials evaluated the impact of Jardiance on the 6-minute walk test in T2DM and non-T2DM patients with HFpEF and HFrEF. Below, FENIX provides thoughts on the failed EMPERIAL studies in the context of BI/Lilly’s ongoing EMPEROR HF outcomes studies as well as readthrough to AstraZeneca, Janssen, and Lexicon.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

New Novo Partnership with Dicerna for RNAi Therapeutics

Novo Nordisk and Dicerna announced a partnership for the discovery and development of RNAi therapeutics targeting liver-related cardio-metabolic diseases including T2DM, NASH, obesity, other chronic liver diseases, and rare diseases. Following the announcement, Dicerna hosted a call with investors to discuss the implications to its business. Below, FENIX provides thoughts on the Novo/Dicerna partnership, particularly in the context of Dicerna’s other existing partnerships including Lilly and Boehringer Ingelheim (separately from the BI/Lilly CV/Met alliance).

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

BI/Lilly Initiate Jardiance Acute HF Study (EMPULSE)

BI/Lilly announced the initiation of a new Jardiance study (EMPULSE) in T2DM and non-T2DM patients who have been hospitalized for acute heart failure. Below, FENIX provides an overview of the trial as well as insights into how the EMPULSE trial appears to be a natural progression of BI/Lilly’s Jardiance LCM strategy.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Jardiance T1DM Adcom Scheduled for Nov 13

FDA has requested an advisory committee on November 13, 2019 to discuss the use of empagliflozin in T1DM. Of note, the empa T1DM adcom appears to be part of a 2-day adcom with Amarin’s REDUCE-IT which is scheduled for November 14. As always, FENIX will provide full coverage and analysis of the adcom. Below, FENIX provides brief thoughts on the empa T1DM adcom including hypotheses as to why the empa T1DM review has progressed to an adcom while Lexicon and AZ received CRLs for sota and dapa, respectively.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Biocon/Mylan Glargine CRL; BI/ZEAL Dual Agonist Moves to Ph2; Vertex Acquires Semma

Three key pieces of news have recently been observed: Biocon/Mylan received a CRL from FDA regarding their bs-glargine Malaysian manufacturing facility, Boehringer Ingelheim is advancing its dual agonist into Ph2 (licensed from Zealand), and Vertex entered into a definitive agreement to acquire Semma Therapeutics. Below, FENIX provides thoughts and insights on the respective news items including the uncertainty around Biocon/Mylan’s glargine in the context of the merger with Pfizer.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.